The whole point of the FDA having a "nutritional supplement" category is to allow people the freedom to buy and sell substances of speculative benefit.
The FDA started cracking down on the entire industry in the early 1990s, before there was a nutritional supplement category. Turns out, a nontrivial number of nutritional supplement makers are in Utah, and Senator Orrin Hatch became their champion. He's done more than most -- possibly more than anyone -- to keep nutritional supplements unregulated. In exchange, he's gotten ridiculous numbers of campaign contributions from the industry. I'd much rather have no nutritional supplement category, and I suspect that there will be multiple attempts to get rid of it the instant Hatch leaves the Senate.
IMO, in many cases with nutritional supplements, it is quite well known what it does, because that stuff has been used for ages and a bunch of observations on it has been gathered.
It's just that, as you say, no one has a motivation to shell out the money to get a certificate for it.
Also, boggling at 100% pure caffeine. I see the appeal to great stupidity there...
IMO, in many cases with nutritional supplements, it is quite well known what it does, because that stuff has been used for ages and a bunch of observations on it has been gathered.
Indeed! And - I'd meant to mention this and forgot, maybe I edit it in later - in the cases of plenty of nutritional supplements, there's actually science out there to read. That science may be insufficient to the FDA's purposes - for instance, it might be toxicology research that addresses only risk not reward, or it might be efficacy in an animal model, or it might be research into how a substance is metabolized and used by the human body that doesn't address efficacy, it may be small weak-powered studies - but that doesn't mean there's no scientific literature on this stuff.
Also, boggling at 100% pure caffeine. I see the appeal to great stupidity there...I thought of an application last night after posting: caffeine is an appetite suppressant. The population of people who aren't just dealing with regular kitchen equipment, the population of people
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I was amused the first time that I saw caffeine pills sold under my pharmacy's "nutritional supplements" category, and joked that "clearly, caffeine is a necessary part of a nutritious diet".
But assuming that Europe's logic for classifying something as a nutritional supplement is the same as FDA's, then having them there actually makes sense.
My impression is that it's a matter of honor/history in China for TCM to be proven to be valid scientifically. And well, there /are/ thousands of years of history backing TCM practices and prescriptions, but the placebo effect is strong and I believe in controlled experiments.
I'm a little confused here. Like, if you could just sell arbitrary prescription drugs as nutritional supplements by simply making no claims about what they do, surely people would be doing so?
Like, if you could just sell arbitrary prescription drugs as nutritional supplements by simply making no claims about what they do, surely people would be doing so?I don't think anybody's saying you can just sell arbitrary prescription drugs as nutritional supplements: first of all, there's patent law for synthetic (synthesized) drugs, and I don't know how it applies, if at all, to nutritional supplements. I don't think you could synthesize a brand-name, patented drug and put it in capsules and sell it as a nutritional supplement, because, if nothing else, the patent-holder's lawyers would hunt you down and ruin your decade. It's only if your synthesized compound has a natural source that you wind up with it also being available as a supplement
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Second, I expect once a drug has been classified as a drug by the FDA, they regulate it as such. Aripiprazole is now available in generic, so no more patent, but that doesn't mean that you can put it in capsules and sell it as a nutritional supplement.
Right, there is at least some classifying of substances as drugs, as opposed to pure packaging regulation; hence the need to actually get a prescription to obtain certain drugs.
But this all raises the question as to whether there are quiet discussions going on in boardrooms at drug discovery companies, asking whether they might do better by making an end-run around FDA approval and going right to market with a "supplement".
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The FDA started cracking down on the entire industry in the early 1990s, before there was a nutritional supplement category. Turns out, a nontrivial number of nutritional supplement makers are in Utah, and Senator Orrin Hatch became their champion. He's done more than most -- possibly more than anyone -- to keep nutritional supplements unregulated. In exchange, he's gotten ridiculous numbers of campaign contributions from the industry. I'd much rather have no nutritional supplement category, and I suspect that there will be multiple attempts to get rid of it the instant Hatch leaves the Senate.
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"What the FDA does regulate foods for a few things ( ... )
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It's just that, as you say, no one has a motivation to shell out the money to get a certificate for it.
Also, boggling at 100% pure caffeine. I see the appeal to great stupidity there...
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Indeed! And - I'd meant to mention this and forgot, maybe I edit it in later - in the cases of plenty of nutritional supplements, there's actually science out there to read. That science may be insufficient to the FDA's purposes - for instance, it might be toxicology research that addresses only risk not reward, or it might be efficacy in an animal model, or it might be research into how a substance is metabolized and used by the human body that doesn't address efficacy, it may be small weak-powered studies - but that doesn't mean there's no scientific literature on this stuff.
Also, boggling at 100% pure caffeine. I see the appeal to great stupidity there...I thought of an application last night after posting: caffeine is an appetite suppressant. The population of people who aren't just dealing with regular kitchen equipment, the population of people ( ... )
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But assuming that Europe's logic for classifying something as a nutritional supplement is the same as FDA's, then having them there actually makes sense.
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I've been known to use the expression "too much blood in my caffeine stream".
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Right, there is at least some classifying of substances as drugs, as opposed to pure packaging regulation; hence the need to actually get a prescription to obtain certain drugs.
But this all raises the question as to whether there are quiet discussions going on in boardrooms at drug discovery companies, asking whether they might do better by making an end-run around FDA approval and going right to market with a "supplement".
Huh -- interesting question...
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